Incident / Investigation Report

Incident / Investigation Report

DR Number:



DR Number:

Investigation Type


This should list the type of investigation
(eg. Process Failure, Operator Error, etc.).











Executive Summary


The executive summary should contain a brief description of the event, root cause found during the investigation and a final summary on product disposition.



















Name (Position)
Signature
Date
Prepared by:


Checked by:


Authorised by:


Approved by:




         Index
Investigation Type ................................ ................................................................ ...... 
Executive Summary ................................ ................................................................ ... 
Index    2
1.0       Event ................................ ................................................................ ............. 
2.0       Batch Chronology ................................ .......................................................... 
3.0       Suspect Causes and Rationales ................................................................ .... 
4.0       Corrective and Preventive actions to be taken................................ ................ 
5.0       Risk Analysis ± Potential impact on other processes ......................................
6.0       Product Disposition ................................................................ ........................ 
7.0       Summary ................................ ................................................................ ....... 
7.1       Root Cause ................................ ................................................................ ... 
7.2       Repeat Event................................ ................................................................ .
7.3       Batch Disposition ................................................................ ........................... 
7.4       Impact on other batches / processes.............................................................. 
8.0       List of Attachments ................................ ........................................................ 
8.1.1    Attachment ± Summary of Investigation Tasks ............................................... 
8.1.2    Attachment ± Summary of Corrective Actions Tasks ...................................... 
8.1.3    Attachment ± Summary of Preventative Actions Tasks................................... 
8.2       Attachment - Investigation meeting minutes ...................................................
8.3       Attachment - Supporting batch documentation ...............................................
8.3.1    Attachment ± Deviation Report/s................................................................ ....
8.3.2    Attachment - Supporting Batch Documentation / Log Books ........................... 
8.3.4    Attachment - Supporting Facilities Data................................ .......................... 
8.3.5    Attachment - Supporting Analytical Data ........................................................ 
8.3.6    Attachment ± Validation Data................................................................ ......... 
8.4       Attachment - Evidence of actions completed ..................................................
8.4.2    Attachment - Employee Awareness Forms..................................................... 
8.4.3    Attachment - SOP Updates ................................ ............................................
8.4.4    Attachment - Training / Assessment Updates ................................................. 





1.0     Event


Description of event and details to be added here.



Process Line(s), Product Name(s), Product Code(s) and Batch No.(s) to be added here.



Initial Scope of the investigation and any immediate action/segregation/blocking of stock for sale should be listed here.




2.0    Batch Chronology


This table is an example of events that may need to be documented in a batch investigation chronology. Table can be customised (or even omitted) to fit the sequence of events in an investigation.


Date
(dd/mm/yyyy)
Time
(24 hrs)
Description
dd/mm/yyyy
00:00
Example ± Batch planned / scheduled
dd/mm/yyyy
00:00
Example ± Batch commenced filling

00:30
Example ± Shipper No at time of event

05:00
Example ± Line Clearance performed after event

06:00
Example ± DR raised at this point


3.0    Suspect Causes and Rationales


No.
Cause Description
Primary / Contributing / Unlikely
3.1

Enter suspect cause here

Choose one type from above

Rationale:
This is where you enter your rationale as to why a suspect cause is likely to be correct or why you have discounted this particular cause



3.2

Enter suspect cause here

Primary / Contributing / Unlikely

Rationale:
This is where you enter your rationale as to why a suspect cause is likely to be correct or why you have discounted this particular cause



3.3

Enter suspect cause here

Primary / Contributing / Unlikely

Rationale:
This is where you enter your rationale as to why a suspect cause is likely to be correct or why you have discounted this particular cause


4.0    Corrective and Preventive actions to be taken


State corrective and preventive actions, which need to be taken and the reasoning behind decisions made.

5.0    Risk Analysis ± Potential impact on other processes


Here is where you outline whether this event could have an impact on any other equipment or processes and your rational as to why you have made this conclusion.


You should also explore whether this is a repeat event or the first time this has occurred.



6.0    Product Disposition

6.1     Product made prior to the event

Here is where you outline the risk assessment and impact to product made prior to the event and rationale as to why it is either acceptable or not.


6.2     Product made during the event





Here is where you outline the risk assessment and impact to product made during the event and rationale as to why it is either acceptable or not.


6.3     Product made after the event

Here is where you outline the risk assessment and impact to product made after the event and rationale as to why it is either acceptable or not.




7.0     Summary


Here is where you write your conclusion to the investigation, you must summarise the overall root cause found during the investigation, the impact on this batch and any other batches and the overall batch disposition.



7.1    Root Cause
State the root cause or suspect cause if root cause was not determined.


7.2    Repeat Event

State if a similar event occurred in the last 12 months and DR reference.

7.3    Batch Disposition
State final batch disposition and reasoning behind the decision.


7.4    Impact on other batches / processes
State if other batches/processes are impacted and reasoning behind the decision.




8.0    List of Attachments



Brief list of attachments to be added here



8.1.1 Attachment ± Summary of Investigation Tasks


Task Description
Responsible
Date
Due
Date
Completed

Enter tasks here















8.1.2 Attachment ± Summary of Corrective Actions Tasks


Task Description
Responsible
Date
Due
Date
Completed

Enter tasks here













8.1.3 Attachment ± Summary of Preventative Actions Tasks


Task Description
Responsible
Date
Due
Date
Completed

Enter tasks here
















Note: Batch release may occur prior to the preventative items being completed


8.2    Attachment - Investigation meeting minutes

8.2.1  Meeting Minutes

If there are multiple meetings or discussions these should be listed on this page




8.3    Attachment - Supporting batch documentation



8.3.1 Attachment ± Deviation Report/s


If there are multiple DR associated with this event then these should be listed on this page.




8.3.2 Attachment - Supporting Batch Documentation / Log Books


If there are exerts from the batch documentation or copies of log book pages associated with this event then these should be listed on this page.



8.3.4 Attachment - Supporting Facilities Data


List copies of in-process checks printed from the production lines.

8.3.5 Attachment - Supporting Analytical Data



Copies of Analytical data associated with this event.




8.3.6 Attachment ± Validation Data


Copies of Validation data associated with this event.


8.4     Attachment - Evidence of actions completed




8.4.2 Attachment - Employee Awareness Forms


Employees counselled as a result of this event should sign a form to say that they understand the nature of their involvement and be filed behind this attachment.



8.4.3 Attachment - SOP Updates


Evidence of critical updates to SOPs to be filed behind this attachment.


8.4.4 Attachment - Training / Assessment Updates


Evidence of critical updates to training and assessment be filed behind this attachment.

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